Hourglass Peripheral Embolization Device

Basic Information

• Brand Name: Hourglass Peripheral Embolization Device
• Primary DI: 00860002787114
• Version / Model: PEP-002-US
• Company Name: EMBOLIC ACCELERATION, LLC
• Labeler DUNS: 114590580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-29
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: d8ba09a5-e45c-4710-a0d1-07a4f63bbe80

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	870.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61632	Non-neurovascular embolization plug, metallic	A non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002787114	GS1

Premarket Submissions

Submission Number	Supplement Number
K200083	000